Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases
Recruiting
Phase 2
Interventional Study
Systemic Lupus Erythematosus
Systemic Sclerosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 8 – 25
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- Stephan Grupp MD PhD · Other
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About This Trial
A subset of autoimmune diseases (ADs) in children and young adults are life-threatening and unresponsive to conventional treatments. In these patients, the delivery of high dose immunosuppressive therapy followed by autologous stem cell transplant (ASCT) offers a treatment strategy capable of purging the pathogenic, autoreactive immune system and an opportunity for "immune reset." This strategy ha…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Age 8 ≤ 25 years at time of enrollment.
2. Severe systemic sclerosis or systemic lupus erythematosus based on specific criteria
3. Adequate organ function status
4. No active, untreated infections.
Exclusion Criteria:
1. Previous hematopoietic stem cell transplant (HSCT) or…
Contacts